meddevicedb.com FDA Device Reference

SYSTEM TEN MODEL 100 SURGICAL SYSTEM

K900003 Class II Traditional
Decision Date
1990-03-16
Sponsor / Applicant
Advanced Osseous Technologies

Technical Specification

510(k) Submission ID K900003
Product Code JDX
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.4580
Decision Date 1990-03-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SYSTEM TEN MODEL 100 SURGICAL SYSTEM received FDA 510(k) clearance under submission number K900003, sponsored by Advanced Osseous Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-03-16.

Classification & Regulation

This clearance is catalogued under FDA product code JDX and 21 CFR 888.4580, within the Orthopedic review panel as a Class II device.